Tradeoff Analysis Appendix D Questionnaires

Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion

Tradeoff Analysis Appendix D Questionnaires

OMB: 0910-0917

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Appendix D

Pretest/Main Study Questionnaires


Pretest/Main Study Questionnaires:

Diagnosed Consumers

IMPORTANT GLOBAL PROGRAMMING NOTES:

  • This annotated questionnaire is color coded:

  • BLUE = The main text of programming notes and logical operators

  • RED= Value names and labels, which are not meant to appear on screen. These correspond to parameters set in the data shell

  • GREY= Variable names (i.e., question numbers). These correspond to variable names in the data shell

  • BLACK= Question stems, response options and instructions that are meant to appear on screen

  • Insert a no back prompt for every screen throughout the survey

  • Include a variable named “CASEID” in the dataset to record a unique identification number for each subject.

  • Include a variable named “COGTEST” in the dataset to record whether the participant is accessing the survey for the cognitive interview phase. This variable can take one of two values: COGTEST= 1 ‘Yes, cognitive interview phase’ or COGTEST = 0 ‘No, not cognitive interview phase’.

    • If COGTEST = 1, skip screener and consent, start at Section A.

  • Include a variable named “EFLAG” in the dataset to record eligibility, where 1 ‘Eligible’ and 0 ‘Ineligible’. Set initial value for all cases to EFLAG = 1 ‘Eligible’.

  • Include a variable named “COHORT” in the dataset to record which version of the DCE participants will complete. This variable can take one of two values: COHORT = 1 ‘Psoriasis’ or COHORT = 2 ‘Diabetes’. See programming note at start of Section A.

    • Dynata will invite respondents to participate in either the psoriasis version of the study or the type 2 diabetes version. The screener will confirm whether each respondent meets the eligibility criteria for his/her respective group.

    • If a respondent is eligible for both versions of the study, they should be assigned to COHORT = 1 ‘Psoriasis’ unless that target sample size for that study has been met.

  • Include a variable named “BLOCK” in the dataset to assign/record which set of DCE tasks participants will complete. This variable can take integer values from 1 to 200. See programming note at top of Section A.

    • After the consent screen and before Section C, Dynata will randomly assign participants a value from 1 – 200 for “BLOCK”.

  • Include a variable named “TIME_TOTAL” in the dataset to record the total amount of time in milliseconds that each respondent takes to complete the survey.

  • Include soft prompts for all questions. If a question is skipped, display the following prompt (or if Dynata survey platform has default soft prompt language, use that):You have not answered one or more questions on this screen. Please make a selection before continuing. Prompt once, and then allow respondent to continue.

[IMPORTANT: Do not change question numbers/names after version submitted for programming. Changing question numbers will cause delays and potentially errors in the program.]


[PROGRAMMER: Include a placeholder for the OMB control number and expiration date, which will need to appear at the bottom of every screen. It should be as unobtrusive as possible: OMB control #: XXXX-XXXX; Exp: MM/DD/YYYY]


[PROGRAMMER: Some questions have conditional piping in item stems or response options that will depend on the study cohort, as captured in the COHORT variable (defined above). The conditional text appears in curly brackets “{ }” with the following rules:


Conditional text

COHORT

Display

{plaque psoriasis \

type 2 diabetes}

1 ‘Psoriasis’

plaque psoriasis

2 ‘Diabetes’

type 2 diabetes

{\ other than insulin}

1 ‘Psoriasis’


2 ‘Diabetes’

other than insulin

{for plaque psoriasis \ other than insulin for type 2 diabetes}

1 ‘Psoriasis’

for plaque psoriasis

2 ‘Diabetes’

other than insulin for type 2 diabetes

{four \ five}

1 ‘Psoriasis’

four

2 ‘Diabetes’

five

{$5.00 \ $4.00}

1 ‘Psoriasis’

$5.00

2 ‘Diabetes’

$4.00


Example: For the bracketed text {plaque psoriasis \ type 2 diabetes}, IF COHORT= 1 ‘Psoriasis’, then display “plaque psoriasis” in place of the bracketed text.


[PROGRAMMER: For question sections that would require more complicated piping, we instead created two distinct sets of questions designated by the suffix _P or _D. The skip logic for those questions is given in separate programming notes.]


[QUOTA REQUIREMENTS:

20% of completes must have low health literacy, defined as S11 >= 3]

[QUESTIONNAIRE]

[----------------------------------------New screen----------------------------------------]


[SECTION A. Diagnosed Consumer BACKGROUND]

[Programmer:

  • IF S5_C_6 ‘Plaque psoriasis’ IS selected AND S5_C_7 ‘T2 diabetes’ NOT selected, SET COHORT = 1 ‘Psoriasis’;

  • ELSE IF S5_C_6 ‘Plaque psoriasis’ NOT selected AND S5_C_7 ‘T2 diabetes’ IS selected, SET COHORT = 2 ‘Diabetes’;

  • ELSE IF S5_C_6 ‘Plague psoriasis IS selected AND S5_C_7 ‘T2 diabetes’ IS selected AND target sample size for psoriasis study NOT met, SET COHORT = 1 ‘Psoriasis’;

  • ELSE (S5_C_6 ‘Plague psoriasis IS selected AND S5_C_7 ‘T2 diabetes’ IS selected AND target sample size for psoriasis study IS met), SET COHORT = 2 ‘T2 diabetes’]


[Programmer:

  • IF COGTEST = 1, SET BLOCK = 1;

  • ELSE IF COGTEST = 0, Randomly assign each participant an integer value from 1 – 200 and record result in the variable BLOCK]




OMB Control No. 0910-NEW

Expiration date: xx/xx/xxxx


According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-NEW and the expiration date is xx/xx/xxxx. The time required to complete this information collection is estimated to average 20 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.


Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.


First, we would like to ask a series of questions about you and your experience with {plaque psoriasis \ type 2 diabetes}.


[Target Health Condition-Duration]

[radio; single punch]

A1_C. How long has it been since you were first diagnosed with {plaque psoriasis \ type 2 diabetes}?

1 Less than 5 years

2 6 – 10 years

3 11 – 15 years

4 16 – 20 years

5 More than 20 years

[Target Health Condition-Perceived Severity]

[SCALE]

A2_C. In your opinion, how severe is your {plaque psoriasis \ type 2 diabetes}?

1

Not at all severe

2

A little

severe

3

Moderately severe

4

Very

severe

5

Extremely severe


[Target Health Condition-Controlled]

[SCALE]

A3. Please rate your agreement or disagreement with the following statement.

I am able to keep my {plaque psoriasis \ type 2 diabetes} under control most of the time.

1

Strongly disagree

2

Somewhat disagree

3

Neither agree nor disagree

4

Somewhat agree

5

Strongly agree



[Target Health Condition-Rx Familiarity]

[SCALE]

A4. How familiar are you with prescription drugs {\ other than insulin} that treat {plaque psoriasis \ type 2 diabetes}?

1

Not at all familiar

2

A little

familiar

3

Moderately familiar

4

Very

familiar

5

Extremely familiar

[Target Health Condition -Rx]

[radio; single punch]

A5. Are you currently taking, or have you ever taken, any prescription drugs {for plaque psoriasis \ other than insulin for type 2 diabetes}?

1 Currently taking

2 Have taken in the past but not currently taking

3 Have never taken [Skip to A7]



[PROGRAMMER:

IF (A5 = 1 ‘Currently taking’ OR A5 = 2 ‘Have taken…’) AND COHORT = 1 ‘Plaque psoriasis’, GO TO A6_P;

ELSE IF (A5 = 1 ‘Currently taking’ OR A5 = 2 ‘Have taken…’) AND COHORT = 2 ‘T2 diabetes’, GO TO A6_D;

ELSE SKIP TO A7]

[Psoriasis-RxType]

[Checkbox; multi-punch]

A6_P. What forms of prescription drugs have you used to treat your plaque psoriasis? (Select all that apply)

A6_P_1. Cream, gel, or ointment put directly on the skin

A6_P_2. Pill or tablet taken by mouth

A6_P_3. Given through a shot under the skin (examples: prefilled pen, syringe)

A6_P_4. Given over a period of time through a needle placed in a vein in your arm (example: infusion or IV)

A6_P_5. Other (please specify)

A6_P_5_Open. [TEXT FIELD]


[IF A6_P_5 ‘Other’ is selected, DISPLAY Text Field A6_P_5_Open.]



[Diabetes-RxType]

[Checkbox; multi-punch]

A6_D. What forms of prescription drugs have you used to treat your type 2 diabetes? (Select all that apply)

A6_D_1. Pill or tablet taken by mouth

A6_D_2. Given through a shot under the skin with a prefilled pen

A6_D_3. Given through a shot under the skin with a syringe

A6_D_4. Other (please specify)

A6_D_4_Open. [TEXT FIELD]


[IF A6_D_4 ‘Other’ is selected, DISPLAY Text Field for A6_D_4_Open.]


[Health Insurance]

[radio; single punch]

A7. Are you now covered by any form of health insurance or health plan? This includes a private insurance plan through your employer, a plan that you purchased yourself, or a government program like Medicare or Medicaid.

1 Yes

2 No [Skip to Section B]

998 Don’t know [Skip to Section B]

[IF A7 = 1 ‘Yes’ GO TO A8, ELSE SKIP TO Section B]


[Rx Coverage]

[Radio; single punch]

A8. Does your current insurance plan help pay for prescription drugs?

1 Yes

2 No

998 Don’t know


[IF COHORT = 1 ‘Plaque psoriasis’, GO TO Section B_P (Plaque Psoriasis);

ELSE IF COHORT = 2 ‘T2 diabetes, GO TO Section B_D (Type 2 diabetes)]


[----------------------------------------New screen----------------------------------------]



[SECTION B_P (plaque Psoriasis). INTRODUCTION TO ATTRIBUTE DESCRIPTIONS]


The purpose of this study is to learn about your preferences for prescription drugs used to treat plaque psoriasis. In this section, we will describe 4 characteristics of psoriasis medicines:

  • Skin clearance after 4 months

  • Risk of rare but serious side effects

  • How the drug is taken

  • Additional information about the drug

As we describe each drug characteristic, we will ask you some questions about how you feel about it. Later in the survey, we will ask you to choose between psoriasis drugs that differ from one another based on these characteristics.

[Randomize THE Order In which Sections B1_P through B4_P are shown to respondentS.]



[----------------------------------------New screen----------------------------------------]

[SECTION B1_P (PSORIASIS). SKIN CLEARANCE]


Skin clearance after 4 months

Psoriasis is a health condition that can cause thick, scaly patches to form on the skin. Doctors sometimes prescribe psoriasis medicines to help their patients with psoriasis have clearer skin. One way to describe how well a prescription drug for psoriasis works is the chance that it will lower the amount of redness, thickness, scaling, and how much skin is covered by these patches, for example, by at least 90%.

In this study, we will ask you to consider the following 3 levels for the chance of seeing 90% clearer skin:

  • 4 out of 10 patients will see at least 90% clearer skin

  • 6 out of 10 patients will see at least 90% clearer skin

  • 8 out of 10 patients will see at least 90% clearer skin


[Importance-Psoriasis - SkinClearance]

[SCALE]

B1_P. How important to you is the chance that a psoriasis drug will give you 90% clearer skin?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B2_P (Psoriasis). Rare But Serious Side Effects]


Rare but serious side effects

Psoriasis drugs can have rare but serious side effects. In this study, we will ask you to consider different combinations of the following serious side effects:

  • Life-threatening allergic reactions

  • Serious infections that may lead to hospitalization or death

Signs of life-threatening allergic reactions may include trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat, or arms.

Serious infections that may lead to hospitalization or death. The infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread through the body.

[Importance-Psoriasis-Risks]

[SCale]

B2_P. How important are the rare but serious side effects of a psoriasis drug to you?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important



[----------------------------------------New screen----------------------------------------]

[SECTION B3_P (Psoriasis). How the drug is taken]


How the drug is taken

Prescription drugs for plaque psoriasis come in many forms. In this study, we will ask you to consider drugs that are taken in one of the 4 following ways:

  • Pill taken by mouth

  • Cream, gel, or ointment put directly on your skin

  • Prefilled pen or syringe. Given through a shot under your skin

  • Infusion or IV. Given over a period of time through a needle placed in a vein in your arm


[Importance-Psoriasis-HowTaken]

[Scale]

B3_P. How important to you is the way you take a psoriasis drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B4_P (Psoriasis): Additional Information]



Additional information about the drug

Prescription drugs may come with additional information about the product. We will ask you to consider the 4 following claims:

  • Improved adherence in patients

  • Doctor preferred

  • #1 preferred by patients

  • Convenient


[Importance-Psoriasis-AddedInfo]

[SCALE]

B4_P. How important to you is the additional information about a psoriasis drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


[IF COHORT = 1 ‘Plaque Psoriasis’, GO TO SECTION C_P (Plaque Psoriasis)]

[----------------------------------------New screen----------------------------------------]


[SECTION B_D (DIABETES). INTRODUCTION TO ATTRIBUTE DESCRIPTIONS]



The purpose of this study is to learn about your preferences for prescription drugs used to treat type 2 diabetes. In this section, we will describe 5 characteristics of diabetes medicines:

  • Change in your average blood sugar level after 6 months

  • How the drug is taken

  • How often the drug is taken

  • Risk of rare but serious side effects

  • Additional information about the drug

As we describe each drug characteristic, we will ask you some questions about how you feel about it. Later in the survey, we will ask you to choose between diabetes drugs that differ from one another based on these characteristics.



[Randomize THE Order In which Sections B1_D through B5_D are shown to respondent.]




[----------------------------------------New screen----------------------------------------]

[SECTION B1_D (DIABETES). CHANGE IN A1c]



Change in average blood sugar level after 6 months

Doctors sometimes prescribe medicines to help people with type 2 diabetes control high blood sugar levels. A1C is a blood test that measures your average blood sugar level over the past 3 months. The goal for most people with type 2 diabetes is an A1C of 7.0% or less. However, your doctor may have set a different personal goal for you based on many things, such as your age or other medical conditions.

In this study, we will ask you to consider the following 3 levels of improved blood sugar:

  • Lower your A1C by 0.5 points

  • Lower your A1C by 1.0 point

  • Lower your A1C by 2.0 points



[Importance-Diabetes-ChangeA1C]

[Scale]

B1_D. How important to you is the amount that your A1C average blood sugar level can be lowered by a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B2_D (DIABETES): HOW THE DRUG IS TAKEN]



How the drug is taken

Prescription drugs to improve blood sugar come in many forms. In this study, we will ask you to consider drugs that are taken in one of the 3 following ways:

  • Pill taken by mouth

  • Given through a shot under your skin with prefilled pen

  • Given through a shot under your skin with a syringe


[Importance-Diabetes-HowTaken]

[Scale]

B2_D. How important to you is the way you take a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B3_D (Diabetes): HOW OFTEN THE DRUG IS TAKEN]



How often the drug is taken

In this study, we will ask you to consider drugs that differ based on how often you need to take them in one of the 4 following ways:

  • Three times a day

  • Two times a day

  • One time a day

  • One time a week



[Importance-Diabetes-Frequency]

[Scale]

B3_D. How important to you is how often you need to take a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B4_D (Diabetes). Rare But Serious Side Effects]


Rare but serious side effects

Type 2 diabetes drugs can have rare but serious side effects. In this study, we will ask you to consider different combinations of the following serious side effects:

  • Life-threatening allergic reactions

  • Dying from heart disease

Signs of life-threatening allergic reactions may include trouble breathing or swallowing, raised bumps (hives), swelling of the face, lips, tongue, throat, or arms, burning eyes, skin pain, red or purple rash with blistering and peeling.

People taking some types of diabetes drugs have a greater chance of dying from heart disease compared to people treated with diet alone.



[Importance-Diabetes-Risks]

[SCALE]

B4_D. How important are the rare but serious side effects of a diabetes drug to you?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important








[----------------------------------------New screen----------------------------------------]

[SECTION B5_D (diabetes): Additional Information]



Additional information about the drug

Prescription drugs may come with additional information about the product. We will ask you to consider the 4 following claims:

  • Improved adherence in patients

  • Doctor preferred

  • #1 preferred by patients

  • Easy to use


[Importance-Diabetes-AddedInfo]

[SCALE]

B5_D. How important to you is the additional information about a diabetes drug?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


[IF COHORT = 2 ‘Type 2 Diabetes’, GO TO SECTION C_D (Diabetes)]




[----------------------------------------New screen----------------------------------------]

[SECTION C_P. PSORIASIS DISCRETE CHOICE EXPERIMENT (DCE)]

[DCE INTRO - Psoriasis]


The purpose of this section is to assess your preferences for prescription drugs that are used to treat adults with moderate to severe plaque psoriasis.

On the next few screens, we will show you several comparisons of prescription drugs to treat moderate to severe plaque psoriasis. The drugs are different from one another based on the 4 characteristics we discussed earlier: skin clearance after 4 months; rare but serious side effects; how the drug is taken; and additional information about the drug.

In all other ways, the drugs are the same, except for the characteristics we show you. For example, every drug has the same common side effects including upper respiratory infection, cough, stuffy nose, sore throat, headache, and diarrhea. This is not the complete list of possible side effects. All the drugs are FDA approved and cost the same.

[----------------------------------------New screen----------------------------------------]

When completing the rest of the survey, please consider the following situation:

Suppose that your doctor says that your current psoriasis treatment is not working as well as they would like. Your doctor recommends that you try a prescription drug to help you have clearer skin.

[----------------------------------------New screen----------------------------------------]

[DCE PRACTICE QUESTION-INTRO - Psoriasis]


Before we start the survey, we’d like you to complete a practice question to get familiar with the task.

On the next screen, we will show you information about two drugs. Both drugs are prescription medicines used to treat moderate to severe plaque psoriasis in adults. The names of the drugs have been changed for this study.

Based on the information shown, please select which of the two drugs you would prefer to take.


[----------------------------------------New screen----------------------------------------]

Based on the information below, which drug would you choose to treat your plaque psoriasis?


Drug A

Drug B

Skin clearance after 4 months

8 out of 10 patients will see at least 90% clearer skin

2 out of 10 patients will see at least 90% clearer skin

Rare but serious side effects

Serious infections that may lead to hospitalization or death

Serious infections that may lead to hospitalization or death

How the drug is taken

Pill taken by mouth

Pill taken by mouth

Additional information about the drug

Doctor preferred

Doctor preferred



[DCE-TRAINING - Psoriasis]

[Radio; single punch]

C0_P. Which drug would you choose to treat your plaque psoriasis?

  1. Drug A [Go to ‘Drug A Debrief’ screen]

  2. Drug B [Go to ‘Drug B Debrief’ screen]


[if C0_P = 1 ‘Drug A’, Go to ‘drug a debrief’ screen;]

[Programmer:

  • IF C0_P = 1 ‘Drug A’, GO TO ‘Drug A Debrief - Psoriasis’ screen

  • IF C0_P = 2 ‘Drug B’, GO TO ‘Drug B Debrief - Psoriasis’ screen]






[----------------------------------------New screen----------------------------------------]

[DRUG A DEBRIEF - PSORIASIS]

In this question, both drugs were exactly the same except that Drug A was more effective at achieving skin clearance compared to Drug B. You chose the more effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.


[----------------------------------------New screen----------------------------------------]


[DRUG B DEBRIEF - PSORIASIS]

Please read these questions carefully. In this question, both drugs were exactly the same except that Drug A was more effective at achieving skin clearance compared to Drug B. You chose the less effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.



[----------------------------------------New screen----------------------------------------]

Now you’re ready to take the rest of the survey. You’ll see more questions like the one you just answered.

In each question, we’ll ask you to choose between two drugs. For each pair, the drugs will differ from each other in more than one way. Please read the information about each drug carefully and consider which option you would choose to treat your plaque psoriasis. Make sure that you consider all 4 characteristics of both drugs in your answers.




[----------------------------------------New screen----------------------------------------]


[PROGRAMMER:

  • Each respondent will complete 8 choice tasks in this section. Show the choice tasks on 8 separate screens.

  • Each task will resemble the question below.

  • Populate the attribute levels in the drug profiles – empty cells in columns labeled Drug A or Drug B – in each choice task according to the experimental design in the Excel file, “CBC Design Psoriasis.xlsx”.

  • Randomize the order of attributes in each DCE choice task

  • Label the questions C1_P – C8_P.]



Based on the information below, which drug would you choose to treat your plaque psoriasis?


Drug A

Drug B

Skin clearance after 4 months



Rare but serious side effects



How the drug is taken



Additional information about the drug





[DCE - Psoriasis]

[Radio; single punch]

C1_P - C8_P. Which drug would you choose to treat your plaque psoriasis?

  1. Drug A

  2. Drug B



[----------------------------------------New screen----------------------------------------]


[AFTER QUESTION C4_P, DISPLAY THE FOLLOWING TEXT]

Make sure that you consider all 4 characteristics of both drugs in your answers. You are halfway through this part of the survey! Please keep going! Your answers are important.

[IF COHORT = 1 ‘Plaque psoriasis’, GO TO C(K+2)]




[----------------------------------------New screen----------------------------------------]

[SECTION C_D. DIABETES DISCRETE CHOICE EXPERIMENT (DCE)]

[DCE INTRO – Diabetes]


The purpose of this section is to assess your preferences for prescription drugs other than insulin that are used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.

On the next few screens, we will show you several comparisons of prescription drugs to treat type 2 diabetes. The drugs are different from one another based on the 5 characteristics we discussed earlier: change in average blood sugar level; how the drug is taken; how often the drug is taken; rare but serious side effects; and additional information about the drug.

In all other ways, the drugs are the same, except for the characteristics we show you. For example, you will not need to change how often you check your blood sugar levels (with a finger stick, for example) for any of the drugs. Also, every drug has the same common side effects including headache, nausea, dizziness, stomach pain, tiredness, cough, and sore throat. This is not the complete list of possible side effects. All the drugs are used along with diet and regular exercise, are FDA approved, and cost the same.



[----------------------------------------New screen----------------------------------------]

When completing the rest of the survey, please consider the following situation:

Suppose that your doctor says that your current diabetes treatment plan is not working to keep your blood sugar under control. Your doctor recommends that you try a prescription drug to help lower your A1C.



[----------------------------------------New screen----------------------------------------]

[DCE PRACTICE QUESTION-INTRO - Diabetes]


Before we start the survey, we’d like you to complete a practice question to get familiar with the task.

On the next screen, we will show you information about two drugs. Both drugs are prescription medicines used to improve blood sugar in adults with type 2 diabetes. The names of the drugs have been changed for this study.

Based on the information shown, please select which of the two drugs you would prefer to take.


[----------------------------------------New screen----------------------------------------]

Based on the information below, which drug would you choose to treat your type 2 diabetes?


Drug A

Drug B

Change in average blood sugar level

Lower A1C by 2.0 points

Example: Change in A1C from 8.5 to 6.5

Lower A1C by 0.5 points Example: Change in A1C from 8.5 to 8.0


How the drug is taken

Pill taken by mouth

Pill taken by mouth

How often the drug is taken

One time a day

One time a day

Rare but serious side effects

Life-threatening allergic reactions

Life-threatening allergic reactions

Additional information about the drug

Easy to use

Easy to use



[DCE-TRAINING - Diabetes]

[Radio; single punch]

C0_D. Which drug would you choose to treat your type 2 diabetes?

  1. Drug A [Go to ‘Drug A Debrief’ screen]

  2. Drug B [Go to ‘Drug B Debrief’ screen]



[if C0_D = 1 ‘Drug A’, Go to ‘drug a debrief’ screen;]

[Programmer:

  • IF C0_D = 1 ‘Drug A’, GO TO ‘Drug A Debrief - Diabetes’ screen

  • IF C0_D = 2 ‘Drug B’, GO TO ‘Drug B Debrief - Diabetes’ screen]




[----------------------------------------New screen----------------------------------------]

[DRUG A DEBRIEF - DIABETES]

In this question, both drugs were exactly the same except that Drug A was more effective at lowering your average blood sugar levels compared to Drug B. You chose the more effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.


[----------------------------------------New screen----------------------------------------]


[DRUG B DEBRIEF - DIABETES]

Please read these questions carefully. In this question, both drugs were exactly the same except that Drug A was more effective at lowering your average blood sugar levels compared to Drug B. You chose the less effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.



[----------------------------------------New screen----------------------------------------]



Now you’re ready to take the rest of the survey. You’ll see more questions like the one you just answered.

In each question, we’ll ask you to choose between two drugs. For each pair, the drugs will differ from each other in more than one way. Please read the information about each drug carefully and consider which option you would choose to treat your type 2 diabetes. Make sure that you consider all 5 characteristics of both drugs in your answers.


[----------------------------------------New screen----------------------------------------]


[PROGRAMMER:

  • Each respondent will complete 8 choice tasks in this section. Show the choice tasks on 8 separate screens.

  • Each task will resemble the question below.

  • Populate the attribute levels in the drug profiles – empty cells in columns labeled Drug A or Drug B – in each choice task according to the experimental design in the Excel file, “CBC Design Diabetes.xlsx”.

  • Randomize the order of attributes in each DCE choice task

  • Label the questions C1_D – C8_D.]



Based on the information below, which drug would you choose to treat your type 2 diabetes?


Drug A

Drug B

Change in average blood sugar level





How the drug is taken



How often the drug is taken



Rare but serious side effects



Additional information about the drug





[DCE - Diabetes]

[Radio; single punch]

C1_D – C8_D. Which drug would you choose to treat your type 2 diabetes?

  1. Drug A

  2. Drug B




[----------------------------------------New screen----------------------------------------]


[AFTER QUESTION C4_D, DISPLAY THE FOLLOWING TEXT]

Make sure that you consider all 5 characteristics of both drugs in your answers. You are halfway through this part of the survey! Please keep going! Your answers are important.


[----------------------------------------New screen----------------------------------------]

[PROGRAMMER: All Participants]

[UX]

[Grid; SINGLE PUNCH]


C9. The following statements refer to the questions that asked you to choose between {plaque psoriasis \ type 2 diabetes} drugs. Please indicate if you agree or disagree with the statements in the grid below.


1

Strongly disagree

2

Somewhat disagree

3

Neither agree nor disagree

4

Somewhat agree

5

Strongly agree

C9_1. The questions were easy to understand

C9_2. I found it easy to answer all the questions

C9_3. I answered all the questions in a way consistent with my preferences


[----------------------------------------New screen----------------------------------------]


Lastly, here are some questions that require you to use numbers to solve the problem. Some are easy, and others are more difficult. Please don’t use a calculator: We’d like you to answer on your own. Remember, almost everyone will have trouble with these questions, so don’t be upset if some are difficult—just do your best!

[SECTION D. NUMERACY]

[NumeracyCoin]

[Numerical Field; integer range 0 – 1,000]


D1. Imagine that you flip a fair coin 1,000 times. What is your best guess about how many times the coin would come up heads in 1,000 flips?

[Numerical Entry] times out of 1,000


[NumeracyLotto]

[Numerical Field; integer range 0 – 1,000]


D2. In the BIG BUCKS LOTTERY, the chance of winning a $10 prize is 1%. What is your best guess about how many people would win a $10 prize if 1,000 people each buy a single ticket to BIG BUCKS LOTTERY?

[Numerical Entry] people


[NumeracySweepstakes]

[Numerical Field]


D3. In ACME PUBLISHING SWEEPSTAKES, the chance of winning a car is 1 in 1,000. What percent of tickets to ACME PUBLISHING SWEEPSTAKES will win a car?

[Numerical Entry] percent


[----------------------------------------New screen----------------------------------------]

[EXIT SCREEN]


You have been very helpful. Thank you for completing this survey!

The purpose of this study is to learn how prescription drug information shape people’s preferences. The drugs we showed you do not actually exist. Please see your medical doctor or other health care professional for questions about your health or {plaque psoriasis \ type 2 diabetes}.

[When participant clicks out of EXIT SCREEN, insert timestamp in data to record time ‘SURVEYTIME_END’]


Pretest/Main Study Questionnaires:

Physicians

IMPORTANT GLOBAL PROGRAMMING NOTES:

  • This annotated questionnaire is color coded:

  • BLUE = The main text of programming notes and logical operators

  • RED= Value names and labels, which are not meant to appear on screen. These correspond to parameters set in the data shell

  • GREY= Variable names (i.e., question numbers). These correspond to variable names in the data shell

  • BLACK= Question stems, response options and instructions that are meant to appear on screen

  • Insert a no back prompt for every screen throughout the survey

  • Include a variable named “CASEID” in the dataset to record a unique identification number for each subject.

  • Include a variable named “COGTEST” in the dataset to record whether the participant is accessing the survey for the cognitive interview phase. This variable can take one of two values: COGTEST = 1 ‘Yes, cognitive interview phase’ or COGTEST = 0 ‘No, not cognitive interview phase’.

    • IF COGTEST = 1, skip screener and consent, start at Section A.

  • Include a variable named “EFLAG” in the dataset to record eligibility, where 1 ‘Eligible’ and 0 ‘Ineligible’. Set initial value for all cases to EFLAG = 1 ‘Eligible’.

  • Include a variable named “COHORT” in the dataset to record which version of the DCE participants will complete. This variable can take one of two values: COHORT = 1 ‘Psoriasis’ or COHORT = 2 ‘Diabetes’. See programming note at start of Section A.

    • Dynata will invite respondents to participate in either the psoriasis version of the study or the type 2 diabetes version. The screener will confirm whether each respondent meets the eligibility criteria for his/her respective group.

    • If a respondent is eligible for both versions of the study, they should be assigned to COHORT = 1 ‘Psoriasis’ unless that target sample size for that study has been met.

  • Include a variable named “BLOCK” in the dataset to assign/record which set of DCE tasks participants will complete. This variable can take integer values from 1 to 200. See programming note at top of Section A.

    • After the consent screen and before Section C, Dynata will randomly assign participants a value from 1 – 200 for “BLOCK”.

  • Include a variable named “TIME_TOTAL” in the dataset to record the total amount of time in milliseconds that each respondent takes to complete the survey.

  • Include soft prompts for all questions. If a question is skipped, display the following prompt (or if Dynata survey platform has default soft prompt language, use that):You have not answered one or more questions on this screen. Please make a selection before continuing. Prompt once, and then allow respondent to continue.

[IMPORTANT: Do not change question numbers/names after version submitted for programming. Changing question numbers will cause delays and potentially errors in the program.]


[PROGRAMMER: Include a placeholder for the OMB control number and expiration date, which will need to appear at the bottom of every screen. It should be as unobtrusive as possible: OMB control #: XXXX-XXXX; Exp: MM/DD/YYYY]


[PROGRAMMER: Some questions have conditional piping in item stems or response options that will depend on the study cohort, as captured in the COHORT variable (defined above). The conditional text appears in curly brackets “{ }” with the following rules:


Conditional text

COHORT

Display

{plaque psoriasis \

type 2 diabetes}

1 ‘Psoriasis’

plaque psoriasis

2 ‘Diabetes’

type 2 diabetes

{four \ five}

1 ‘Psoriasis’

four

2 ‘Diabetes’

five


Example: For the bracketed text {plaque psoriasis \ type 2 diabetes}, IF COHORT= 1 ‘Psoriasis’, then display “plaque psoriasis” in place of the bracketed text.


[PROGRAMMER: For question sections that would require more complicated piping, we instead created two distinct sets of questions designated by the suffix _P or _D. The skip logic for those questions is given in separate programming notes.]

[Questionnaire]

[----------------------------------------New screen----------------------------------------]


[SECTION A. PHYSICIAN BACKGROUND]

[Programmer:

  • IF S6_M_6 ‘Plaque psoriasis’ IS selected AND S6_M_7 ‘T2 diabetes’ NOT selected, SET COHORT = 1 ‘Psoriasis’;

  • ELSE IF S6_M_6 ‘Plaque psoriasis’ NOT selected AND S6_M_7 ‘T2 diabetes’ IS selected, SET COHORT = 2 ‘Diabetes’;

  • ELSE IF S6_M_6 ‘Plague psoriasis is selected AND S6_M_7 ‘T2 diabetes’ IS selected AND target sample size for psoriasis study NOT met, SET COHORT = 1 ‘Psoriasis’;

  • ELSE (S6_M_6 ‘Plague psoriasis IS selected AND S6_M_7 ‘T2 diabetes’ IS selected AND target sample size for psoriasis study IS met), SET COHORT = 2 ‘T2 diabetes’]


[Programmer:

IF COGTEST = 1, SET BLOCK = 1;

ELSE IF COGTEST = 0, Randomly assign each participant an integer value from 1 – 200 and record result in the variable BLOCK]



First, we would like to ask a series of questions about you and your practice.


[PracticeSize]

[RADIO; single punch]

A1_M. How would you classify your practice?

1 Solo

2 Small group practice (2-10 HCPs)

3 Large group practice (>10 HCPs)


[PracticeSetting]

[RADIO; Single punch]

A2_M. Do you practice at an academic or teaching hospital?

1 Yes

2 No



[----------------------------------------New screen----------------------------------------]

[SECTION B_P (PLAQUE PSORIASIS). INTRODUCTION TO ATTRIBUTE DESCRIPTIONS]

The purpose of this study is to learn about your preferences for prescription medications indicated for adult patients with moderate to severe chronic plaque psoriasis. In this section, we will describe 4 characteristics of psoriasis medications:

  • Skin clearance after 16 weeks

  • Risk of rare but serious adverse reactions

  • Dosage form / route of administration

  • Additional information about the drug

As we describe each characteristic, we will ask you some questions about how you feel about it. Later in the survey, we will ask you to choose between psoriasis medications that differ from one another based on these characteristics for a hypothetical patient.



[Randomize THE Order In which Sections B1_P through B4_P are shown to respondent.]




[----------------------------------------New screen----------------------------------------]

[SECTION B1_P (PSORIASIS). SKIN CLEARANCE]



Skin clearance after 16 weeks

One way to measure the effectiveness of plaque psoriasis medications is the likelihood of achieving an improvement in the Psoriasis Area and Severity Index (PASI). The PASI assesses and grades the severity of psoriatic lesions on a numerical scale. A PASI 90 indicates that a patient achieves skin clearance equivalent to a 90% or greater reduction in PASI score relative to baseline.

In this study, we will ask you to consider the following 3 levels of efficacy:

  • 40% of patients achieve PASI 90

  • 60% of patients achieve PASI 90

  • 80% of patients achieve PASI 90


[Importance-Psoriasis-SkinClearance]

[SCALE]

B1_P. How important to you is the likelihood that your patients will achieve PASI 90 when you prescribe a psoriasis medication?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B2 (Psoriasis). Rare But Serious Adverse Reactions]


Rare but serious adverse reactions

Prescription psoriasis medications can have rare but serious adverse reactions. In this study, we will ask you to consider different combinations of the following serious adverse reactions:

  • Life-threatening hypersensitivity reactions

  • Potentially fatal, serious infections

Life-threatening hypersensitivity reactions include angioedema and anaphylaxis.

Reported serious infections have been potentially fatal and include active tuberculosis (TB), invasive fungal infections (for example, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis), and bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

[Importance-Psoriasis-Risks]

[Scale]

B2_P. How important to you are rare but serious adverse reactions when you prescribe a psoriasis medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important






[----------------------------------------New screen----------------------------------------]

[SECTION B3_P (Psoriasis). ROUTE OF ADMINISTRTION]



Dosage form / route of administration

Psoriasis medications differ from one another in how they are administered. In this study, we will ask you to consider psoriasis medications with one of the following 4 dosage forms/routes of administration:

  • Oral tablet

  • Topical cream, gel, or ointment

  • Subcutaneous injection

  • Intravenous infusion



[Importance-Psoriasis-HowTaken]

[SCALE]

B3_P. How important to you is the dosage form/route of administration when you prescribe a psoriasis medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


[----------------------------------------New screen----------------------------------------]

[SECTION B4_P (Psoriasis). ADDITIONAL INFORMATION CLAIMS]



Additional information about the drug

Prescription drugs may come with additional information about the product. We will ask you to consider the 4 following claims:

  • Improved adherence in patients

  • Doctor preferred

  • #1 preferred by patients

  • Convenient


[Importance-Psoriasis-AddedInfo]

[SCALE]

B4_P. How important to you is the additional information about the product when you prescribe a psoriasis medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important



[IF COHORT = 1 ‘Plaque Psoriasis’, GO TO SECTION C_P (Plaque Psoriasis)]



[----------------------------------------New screen----------------------------------------]

[SECTION B_D (DIABETES). INTRODUCTION TO ATTRIBUTE DESCRIPTIONS]



The purpose of this study is to learn about your preferences for prescription medications indicated for adult patients with type 2 diabetes mellitus. In this section, we will describe 5 characteristics of type 2 diabetes medications:

  • Change in average blood glucose level after 26 weeks

  • Dosage form / route of administration

  • Dose frequency

  • Risk of rare but serious adverse reactions

  • Additional information about the drug

As we describe each characteristic, we will ask you some questions about how you feel about it. Later in the survey, we will ask you to choose between type 2 diabetes medications that differ from one another based on these characteristics for a hypothetical patient.



[Randomize THE Order In which Sections B1_D through B5_D are shown to respondent.]




[----------------------------------------New screen----------------------------------------]

[SECTION B1_D (Diabetes). CHANGE IN A1c]



Change in average blood glucose level after 26 weeks

A1C is the metric typically used to assess glycemic status in clinical trials demonstrating the benefits of improved glycemic control. In its “Standards of Medical Care in Diabetes”, the American Diabetes Association (ADA) recommends an A1C goal of 7.0% or less for many nonpregnant adult patients with type 2 diabetes mellitus if it can be achieved safely without significant hypoglycemia or other adverse effects of treatment. However, less stringent A1C goals may be appropriate for patients with limited life expectancy, or where the harms of treatment are greater than the benefits.

In this study, we will ask you to consider the following 3 levels of efficacy:

  • 0.5-point reduction in A1C

  • 1.0-point reduction in A1C

  • 2.0-point reduction in A1C

[Importance-Diabetes-ChangeA1C]

[Scale]

B1_D. How important to you is the amount that A1C levels can be reduced when you prescribe a type 2 diabetes medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B2_D (Diabetes): ROUTE OF ADMINISTRATION]



Dosage form and route of administration

Type 2 diabetes medications differ from one another in how they are administered. In this study, we will ask you to consider the following 3 dosage forms/routes of administration:

  • Oral tablet

  • Subcutaneous injection with prefilled pen

  • Subcutaneous injection with a syringe


[Importance-Diabetes-HowTaken]

[Scale]

B2_D. How important to you is the dosage form/route of administration when you prescribe a type 2 diabetes medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B3_D (Diabetes): DOSING FREQUENCY]



Dose Frequency

In this study, we will ask you to consider the following 4 levels of dose frequency:

  • Three times a day

  • Twice daily

  • Once daily

  • Once weekly



[Importance-Diabetes-Frequency]

[Scale]

B3_D. How important to you is dose frequency when you prescribe a type 2 diabetes medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important




[----------------------------------------New screen----------------------------------------]

[SECTION B4_D (Diabetes). Rare But Serious Adverse Reactions]


Rare but serious adverse reactions

Type 2 diabetes medications can have rare but serious adverse reactions. In this study, we will ask you to consider different combinations of the following serious adverse reactions:

  • Life-threatening hypersensitivity reactions

  • Cardiovascular mortality

Life-threatening hypersensitivity reactions include anaphylaxis, angioedema, and Stevens-Johnson Syndrome.

The administration of some medications is associated with increased risk of cardiovascular mortality as compared to treatment with diet alone.



[Importance-Diabetes-Risks]

[Scale]

B4_D. How important to you are rare but serious adverse reactions when you prescribe a type 2 diabetes medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important

































[----------------------------------------New screen----------------------------------------]

[SECTION B5_D (Diabetes): Additional Information]



Additional information about the drug

Prescription drugs may come with additional information about the product. We will ask you to consider the 4 following claims:

  • Improved adherence in patients

  • Doctor preferred

  • #1 preferred by patients

  • Easy to use


[Importance-Diabetes-AddedInfo]

[SCALE]

B5_D. How important to you is the additional information about the product when you prescribe a type 2 diabetes medication to your patients?

1

Not at all important

2

A little

important

3

Somewhat important

4

Very

important

5

Extremely important


[IF COHORT = 2 ‘Type 2 Diabetes’, GO TO SECTION C_D (Diabetes)]



[----------------------------------------New screen----------------------------------------]

[SECTION C_P. PSORIASIS DISCRETE CHOICE EXPERIMENT (DCE)]

[DCE INTRO - Psoriasis]


The purpose of this section is to assess how you make decisions when prescribing medications indicated for the treatment of adult patients with moderate to severe plaque psoriasis.

On the next few screens, you will see several paired choices for prescription medications to treat moderate to severe plaque psoriasis. The medications are different from one another based on the 4 characteristics we discussed earlier: skin clearance after 16 weeks; rare but serious adverse reactions; dosage form/route of administration; and additional information about the drug.

In all other ways, you may assume the medications are similar, except for the characteristics we show you. For example, every drug has the same common adverse reactions including secondary infections (e.g., upper respiratory, sinusitis), nasopharyngitis, headache, and diarrhea. This is not the complete list of possible side effects. Also you may assume that all the medications are FDA approved and are covered at the same level by the patient’s insurance so that they cost the same.


[----------------------------------------New screen----------------------------------------]

When completing the rest of the survey, please assume that a patient with the following characteristics asked you for help in treating their chronic plaque psoriasis.

Patient profile

Sex

Male

Age

44 years old

PASI score

19

Psoriasis duration

18 years

Prior treatment

Patient is not responsive to first line therapy

Contraindications

None


[----------------------------------------New screen----------------------------------------]

[DCE PRACTICE QUESTION-INTRO - Psoriasis]


Before we start the survey, we’d like you to complete a practice question to get familiar with the task.

On the next screen, we will show you information about two drugs. Both drugs are prescription medications used to treat moderate to severe plaque psoriasis in adults. The names of the drugs have been changed for this study.

Based on the information shown, please select which of the two drugs you would prefer to prescribe.



[----------------------------------------New screen----------------------------------------]

Based on the information below, which medication would you prescribe to the example patient?


Drug A

Drug B

Skin clearance after 16 weeks

80% of patients achieve PASI 90

20% of patients achieve PASI 90

Rare but serious adverse reactions

Potentially fatal, serious infections

Potentially fatal, serious infections

Dose form / route of administration

Oral tablet

Oral tablet

Additional information about the drug

Doctor preferred

Doctor preferred



[DCE-TRAINING - Psoriasis]

[Radio; single punch]

C0_P. Which drug would you choose to treat your plaque psoriasis?

  1. Drug A [Go to ‘Drug A Debrief’ screen]

  2. Drug B [Go to ‘Drug B Debrief’ screen]


[if C0_P = 1 ‘Drug A’, Go to ‘drug a debrief’ screen;]

[Programmer:

  • IF C0_P = 1 ‘Drug A’, GO TO ‘Drug A Debrief - Psoriasis’ screen

  • IF C0_P = 2 ‘Drug B’, GO TO ‘Drug B Debrief - Psoriasis’ screen]






[----------------------------------------New screen----------------------------------------]

[DRUG A DEBRIEF - PSORIASIS]

In this question, both drugs were exactly the same except that Drug A was more effective at achieving skin clearance compared to Drug B. You chose the more effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.


[----------------------------------------New screen----------------------------------------]


[DRUG B DEBRIEF - PSORIASIS]

Please read these questions carefully. In this question, both drugs were exactly the same except that Drug A was more effective at achieving skin clearance compared to Drug B. You chose the less effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.



[----------------------------------------New screen----------------------------------------]



Now you’re ready to take the rest of the survey. You’ll see more questions like the one you just answered.

In each question, we’ll ask you to choose between two drugs. For each pair, the drugs will differ from each other in more than one way. Please read the information about each drug carefully and consider which option you would choose to treat the hypothetical patient with plaque psoriasis. Make sure that you consider all 4 characteristics of both drugs in your answers.



[----------------------------------------New screen----------------------------------------]


[PROGRAMMER:

  • Each respondent will complete 8 choice tasks in this section. Show the choice tasks on 8 separate screens.

  • Each task will resemble the question below.

  • Populate the attribute levels in the drug profiles – empty cells in columns labeled Drug A or Drug B – in each choice task according to the experimental design in the Excel file, “CBC Design Psoriasis.xlsx”.

  • Randomize the order of attributes in each DCE choice task

  • Label the questions C1_P – C8P.]


Based on the information below, which medication would you prescribe to the example patient?


Drug A

Drug B

Skin clearance after 16 weeks



Rare but serious adverse reactions



Dose form / route of administration



Additional information about the drug





[DCE - Psoriasis]

[SINGLE punch]

C1_P - C8_P. Which drug would you prescribe to the patient?

  1. Drug A

  2. Drug B



[----------------------------------------New screen----------------------------------------]


[AFTER QUESTION C4_P, DISPLAY THE FOLLOWING TEXT]

Make sure that you consider all 4 characteristics of both drugs in your answers. You are halfway through this part of the survey! Please keep going! Your answers are important.

[IF COHORT = 1 ‘Plaque psoriasis’, GO TO C(K+2)]



[----------------------------------------New screen----------------------------------------]

[SECTION C_D. DIABETES DISCRETE CHOICE EXPERIMENT (DCE)]

[DCE INTRO – Diabetes]



The purpose of this section is to assess how you make decisions when prescribing medications other than insulin that are indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.

On the next few screens, you will see several paired choices for prescription medications to treat type 2 diabetes mellitus. The medications are different from one another based on the 5 characteristics we discussed earlier: change in average blood glucose level; dosage form/route of administration; dose frequency; rare but serious adverse reactions; and additional information about the drug.

In all other ways, you may assume the medications are similar, except for the characteristics we show you. For example, every drug has the same common adverse reactions including headache, nausea, dizziness, abdominal pain, fatigue, cough, and pharyngitis. This is not the complete list of possible side effects. Also, you may assume that the medications are FDA approved for use as either a monotherapy or combination therapy along with metformin and are covered at the same level by the patient’s insurance so that they cost the same.


[----------------------------------------New screen----------------------------------------]

When completing the rest of the survey, please assume that a patient with the following characteristics asked you for help in treating their type 2 diabetes.

Patient profile

Sex

Female

Age

57 years old

A1C

8.5

Type 2 diabetes duration

4 years

Prior treatment

Treated with stable metformin dose for past 3 months plus lifestyle intervention. Patient is no longer responsive to first line pharmacological therapy.


Contraindications

None



[----------------------------------------New screen----------------------------------------]

[DCE PRACTICE QUESTION-INTRO - Diabetes]


Before we start the survey, we’d like you to complete a practice question to get familiar with the task.

On the next screen, we will show you information about two drugs. Both drugs are prescription medications used to improve glycemic control adults with type 2 diabetes mellitus. The names of the drugs have been changed for this study.

Based on the information shown, please select which of the two drugs you would prefer to prescribe.



[----------------------------------------New screen----------------------------------------]

Based on the information below, which medication would you prescribe to the example patient?


Drug A

Drug B

Change in average blood glucose level

2.0-point reduction in A1C

Change in A1C from 8.5 to 6.5

0.5-point reduction in A1C Change in A1C from 8.5 to 8.0


Dosage form / route of administration

Oral tablet

Oral tablet

Dose frequency

Once daily

Once daily

Rare but serious adverse reactions

Life-threatening hypersensitivity reactions

Life-threatening hypersensitivity reactions

Additional information about the drug

Easy to use

Easy to use



[DCE-TRAINING - Diabetes]

[Radio; single punch]

C0_D. Which drug would you prescribe to the patient?

  1. Drug A [Go to ‘Drug A Debrief’ screen]

  2. Drug B [Go to ‘Drug B Debrief’ screen]



[if C0_D = 1 ‘Drug A’, Go to ‘drug a debrief’ screen;]

[Programmer:

  • IF C0_D = 1 ‘Drug A’, GO TO ‘Drug A Debrief - Diabetes’ screen

  • IF C0_D = 2 ‘Drug B’, GO TO ‘Drug B Debrief - Diabetes’ screen]






[----------------------------------------New screen----------------------------------------]

[DRUG A DEBRIEF - DIABETES]

In this question, both drugs were exactly the same except that Drug A was more effective at lowering A1C compared to Drug B. You chose the more effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.


[----------------------------------------New screen----------------------------------------]


[DRUG B DEBRIEF - DIABETES]

Please read these questions carefully. In this question, both drugs were exactly the same except that Drug A was more effective at lowering A1C compared to Drug B. You chose the less effective option.

In the following questions, the drugs we show you will differ in more than one way. Please look very carefully at each drug and consider which option you would actually choose.



[----------------------------------------New screen----------------------------------------]



Now you’re ready to take the rest of the survey. You’ll see more questions like the one you just answered.

In each question, we’ll ask you to choose between two drugs. For each pair, the drugs will differ from each other in more than one way. Please read the information about each drug carefully and consider which option you would choose to treat the hypothetical patient with type 2 diabetes mellitus. Make sure that you consider all 5 characteristics of both drugs in your answers.



[----------------------------------------New screen----------------------------------------]


[PROGRAMMER:

  • Each respondent will complete 8 choice tasks in this section. Show the choice tasks on 8 separate screens.

  • Each task will resemble the question below.

  • Populate the attribute levels in the drug profiles – empty cells in columns labeled Drug A or Drug B – in each choice task according to the experimental design in the Excel file, “CBC Design Diabetes.xlsx”.

  • Randomize the order of attributes in each DCE choice task

  • Label the questions C1_D – C8_D.]



Based on the information below, which medication would you prescribe to the example patient?


Drug A

Drug B

Change in average blood glucose level



Dosage form / route of administration



Dose frequency



Rare but serious adverse reactions



Additional information about the drug





[DCE - Diabetes]

[Radio; single punch]

C1_D – C8_D. Which drug would you prescribe to the patient?

  1. Drug A

  2. Drug B





[----------------------------------------New screen----------------------------------------]


[AFTER QUESTION C4_D, DISPLAY THE FOLLOWING TEXT]

Make sure that you consider all 5 characteristics of both drugs in your answers. You are halfway through this part of the survey! Please keep going! Your answers are important.


[----------------------------------------New screen----------------------------------------]

[PROGRAMMER: All Participants]

[UX]

[Grid; single punch]

C9. The following statements refer to the questions that asked you to choose between {plaque psoriasis \ type 2 diabetes} medications. Please indicate if you agree or disagree with the statements in the grid below.


1

Strongly disagree

2

Somewhat disagree

3

Neither agree nor disagree

4

Somewhat agree

5

Strongly agree

C9_1. The questions were easy to understand

C9_2. I found it easy to answer all the questions

C9_3. I answered all the questions in a way consistent with my preferences




[----------------------------------------New screen----------------------------------------]


Lastly, here are some questions that require you to use numbers to solve the problem. Some are easy, and others are more difficult. Please don’t use a calculator: We’d like you to answer on your own. Remember, almost everyone will have trouble with these questions, so don’t be upset if some are difficult—just do your best!

[SECTION D. NUMERACY]

[NumeracyCoin]

[Numerical Field; integer range 0 – 1,000]


D1. Imagine that you flip a fair coin 1,000 times. What is your best guess about how many times the coin would come up heads in 1,000 flips?

[Numerical Entry] times out of 1,000


[NumeracyLotto]

[Numerical Field; integer range 0 – 1,000]


D2. In the BIG BUCKS LOTTERY, the chance of winning a $10 prize is 1%. What is your best guess about how many people would win a $10 prize if 1,000 people each buy a single ticket to BIG BUCKS LOTTERY?

[Numerical Entry] people


[NumeracySweepstakes]

[Numerical Field]


D3. In ACME PUBLISHING SWEEPSTAKES, the chance of winning a car is 1 in 1,000. What percent of tickets to ACME PUBLISHING SWEEPSTAKES will win a car?

[Numerical Entry] percent




[----------------------------------------New screen----------------------------------------]

[EXIT SCREEN]


You have been very helpful. Thank you for completing this survey!

The purpose of this study is to learn how prescription drug information shape people’s preferences. The drugs we showed you do not actually exist.

[When participant clicks out of EXIT SCREEN, insert timestamp in data to record time ‘SURVEYTIME_END’]





D-62


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AuthorBrewington, Micaela
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File Created2023-09-02

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